Skip to content

Mobile Health Technology as an Intervention for Diabetes Self-Management

Use of Mobile Health Technology as an Intervention for Type II Diabetes Self-Management

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01546844
Acronym
Care4Life
Enrollment
500
Registered
2012-03-07
Start date
2012-03-31
Completion date
2013-02-28
Last updated
2012-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes Mellitus

Keywords

SMS, text, text messages, text messaging, diabetes, diabetes mellitus, type II diabetes, type II diabetes mellitus, type 2 diabetes, type 2 diabetes mellitus, Beacon

Brief summary

This purpose of this is study is to evaluate the effectiveness of an interactive mobile health information service, Care4Life, in supporting patient self-management of Type II Diabetes Mellitus.

Detailed description

This study evaluates the effectiveness of an interactive mobile health information service, Care4Life, in supporting patient self-management through its ability to facilitate patient education, behavior change, and improved adherence with standard care practices. The study population comprises adults who have been diagnosed with Type 2 diabetes mellitus (DM) and a hemoglobin A1c (HbA1c) test above 8% in the past year. All members of the study population are treated at primary care clinics under the auspices of the Utah Beacon Community Program, which aims to improve health through use of health information technology. We will compare outcomes in two groups within this population: patients with DM who enroll in Care4Life (in addition to receiving standard care) to patients with DM who receive standard care from their physician. We will compare these groups both within the clinic and at an aggregated, overall level. This study relies on the use of information and communications technology (ICT) in supporting patient-empowerment strategies. Features of successful diabetes care programs for improving adherence to standards of care, such as the use of diabetes self-management education, checklists that mirror guidelines, and automated reminders are well suited to delivery using an interactive mobile health platform. Research Questions This study will evaluate the efficacy of the Care4Life mHealth program by: 1. Evaluating if a short message service via cell phone texting (SMS) protocol will lead to improvements in clinical, utilization and satisfaction outcomes for patients with DM compared to patient who receive standard care. 2. Evaluating if an SMS protocol can be readily adopted by an adult population in both urban and rural areas with a time-consuming chronic illness. Targeted outcomes include: 1. Improved measures of diabetes control, demonstrated as HbA1c percentage levels ≤ 8%; improved blood pressure (BP) control, demonstrated as BP ≤ 140/90 millimeters mercury (mm Hg); and lower body mass index (BMI) among users of the SMS-based tool. 2. Improved knowledge of self-care and disease management practices among adult patients with diabetes treated in Beacon clinics in the Salt Lake Metropolitan Statistical Area (Salt Lake, Tooele, and Summit counties). 3. Dissemination of results and proof of concept with the broader healthcare community in Utah. The mobile centric diabetes support service at the center of our study is Voxiva's Care4Life platform, which is an interactive mobile application designed to educate participants, encourage behavior change and promote adherence to their prescribed DM treatment protocol. It includes a series of SMS-based tools that have been developed in collaboration with the Instituto Carso de la Salud, located in Mexico. The service sends content relevant to the target participants and their standard treatment protocol. Care4Life delivers an individually tailored diabetes education and management plan based on data that are collected from patients at enrollment and added to the participant's personal health profile. The SMS protocol draws on the experience of a number of interventions that have been independently studied and shown to improve health outcomes. Care4Life functionality consists of the following components: (1) a diabetes diary that can be used to develop a history of glucose levels and trigger alerts and feedback based on the participant's results; (2) health education with content tailored to the participant's health profile; (3) medication adherence reminders and monitoring; (4) medical appointment reminders; (5) a database that allows a participant to record and monitor her/his weight, BMI, blood pressure and laboratory results; and (6) a health portal that allows a participant to review his/her data, obtain advice and guidance based on the information entered, and manage his/her preferences.

Interventions

OTHERParticipation in Care4Life

Text message service to aid patients with self-management of type II Diabetes Mellitus. Includes online access to patient data and management of health goals.

Sponsors

Center for Technology and Aging
CollaboratorUNKNOWN
Voxiva
CollaboratorUNKNOWN
HealthInsight
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Laboratory test for HbA1c ≥ 8% within the past year * Clinical diagnosis of DM * Age \> 18 years old * Patient in a Beacon clinic * Cell phone ownership or willingness to acquire a cell phone capable of receiving and sending SMS messages * Women who are not pregnant

Exclusion criteria

* Failure to meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Change in Hemoglobin A1c - In control, over time.3, 6, 9, and 12 monthsHemoglobin A1c - In control as assessed by laboratory results of blood draw taken from patient's clinic. In control means a result of \<9%.

Secondary

MeasureTime frameDescription
Change in Blood Pressure Control over time3, 6, 9, 12 monthsImproved blood pressure (BP) control as demonstrated as BP ≤ 140/90 millimeters mercury (mm Hg)
Change in BMI over time3, 6, 9, 12 monthsLower body mass index (BMI) among users of the SMS-based tool.
Disease Management12 monthsImproved knowledge of self-care and disease management practices among adult patients with diabetes treated in Beacon clinics in the Salt Lake Metropolitan Statistical Area (Salt Lake, Tooele, and Summit counties).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026